Clearance Summary
I.V. START KITS received FDA 510(k) clearance under submission number K875315, sponsored by Ni-Med, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1988-02-17.
- Submission: K875315
- Applicant / Sponsor: Ni-Med, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 1988-02-17
Classification & Regulation
This clearance is catalogued under FDA product code LRS and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.